Clinical Trials Logo

Clinical Trial Summary

This clinical trial adds high-dose ascorbate (vitamin C) to the standard of care regimen for metastatic pancreatic adenocarcinoma (a type of pancreatic cancer). Subjects are randomized between a control group (standard treatment) and an intervention group (pharmacologic ascorbate in addition to the standard treatment).


Clinical Trial Description

One of the standard treatments for metastatic pancreatic adenocarcinoma is nab-paclitaxel with gemcitabine. This standard therapy administers chemotherapy once per week for three weeks; patients then get a 'rest week' to complete the cycle (1 cycle = 4 weeks). This study adds 75 grams of ascorbate (vitamin C, sometimes called pharamcological ascorbate because the dose is so high) to standard therapy. The ascorbate is administered intravenously - through a vein in the arm. Participants in the control group will: - receive gemcitabine and nab-paclitaxel chemotherapy, which is standard for their cancer. - undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays Participants in the intervention group will: - receive 75 grams of ascorbate 3 times per calendar week for each week of the chemotherapy cycle. - undergo imaging which is standard for their cancer and therapy. This can include CT scans, PET scans, and X-rays - provide blood samples to determine the biological effects, if any, the ascorbate has on the body during therapy. This active therapy portion lasts until the disease progresses and a new treatment needs to be adopted - this can be months to years. If disease progresses, participants go back to standard follow-up for their caner and the new/additional therapy their doctors prescribe. However, it is very important we remain in contact with participants; they will have life-long follow-up for this study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02905578
Study type Interventional
Source University of Iowa
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 28, 2018
Completion date December 31, 2025

See also
  Status Clinical Trial Phase
Terminated NCT05435053 - Irreversible Electroporation + Nivolumab for Patients With Metastatic Pancreatic Cancer Phase 2
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Recruiting NCT06065891 - Para-aortic Lymph Node Metastasis in Resectable Pancreatic Cancer N/A
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05048524 - Peri-operative SLOG for Localized Pancreatic Cancer Phase 2
Suspended NCT05124743 - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Recruiting NCT05679674 - Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer N/A
Recruiting NCT05501379 - Comparison of the Physical Activity in Cancer Patients Assessed by Questionnaire and Motion Tracker
Recruiting NCT04851106 - Evaluation of Endoscopic Ultrasound Shear Wave Elastography (EUS-SWE) for the Diagnosis of Pancreatic Adenocarcinoma.
Enrolling by invitation NCT04466189 - Prospective Cohort Study of Pancreatic Cancer Patients Treated With Proton Beam Therapy
Not yet recruiting NCT06036563 - Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
Terminated NCT01313416 - Gemcitabine and CT-011 for Resected Pancreatic Cancer Phase 2
Recruiting NCT01411072 - Biomarker Directed Adjuvant Chemotherapy for Resected Pancreas Cancer N/A
Active, not recruiting NCT01448668 - Iscador Qu as Supportive Treatment in Pancreatic Cancer (Union for International Cancer Control, UICC Stages II-IV) N/A
Completed NCT01155882 - Registry Study - Whipple at the Splenic Artery
Recruiting NCT04970056 - Pancreatic Cancer Early Detection Consortium
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Withdrawn NCT03682744 - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC) Phase 1